Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

Recruitment & Eligibility

Status: RECRUITING

Sex: Female

Target Recruitment: 136

Inclusion Criteria

Treatment-naïve breast cancer female patients aged ≥ 18 years and ≤ 75 years;
Histopathologically confirmed early or locally advanced triple-negative invasive breast cancer according to the latest ASCO/CAP guidelines, meeting the following conditions: (1) pathological type is triple-negative, specifically: ER negative: IHC < 1%, PR negative: IHC < 1%, HER2 negative: IHC 0/1 + or IHC2 + but ISH negative;
Clinical stage II-III invasive breast cancer with measurable lesions according to RECIST 1.1;
ECOG score 0-1;
Able to tolerate preoperative and postoperative adjuvant radiotherapy after assessment by a radiologist;
Appropriate level of organ function
Patients voluntarily participate in and sign the informed consent form, are expected to have good compliance and cooperate with the study according to the requirements of the protocol.

Exclusion Criteria

Patients with metastatic breast cancer or bilateral breast cancer;
Patients with inflammatory breast cancer or occult breast cancer;
Patients received any anti-tumor therapy within 12 months before signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy or tumor embolization;
Patients previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or other treatments against PD-1/PD-L1 inhibitors;
Female patients who are pregnant and lactating, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial.
Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, and the subject has a known history of psychotropic drug abuse, alcoholism ;
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); positive hepatitis B surface antigen (HBsAg) test, or positive hepatitis B core antibody (HBcAb) test followed by positive HBV-DNA test (HBV-DNA test was performed only in patients with negative HBsAg test and positive HBcAb test); positive hepatitis C virus (HCV) antibody test followed by positive HCV-RNA test (HCV-RNA test was performed only in patients with positive HCV antibody test)
Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
adebrelimab plus stereotactic radiotherapy and chemotherapy	adebrelimab plus stereotactic radiotherapy followed by adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)	-
adebrelimab plus nab-paclitaxel + carboplatin	adebrelimab plus chemotherapy (nab-paclitaxel + carboplatin)	-

Primary Outcome Measures

Name	Time	Method
tpCR	6 months	total pathologic complete response

Secondary Outcome Measures

Name	Time	Method

Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC

Recruitment & Eligibility

Study & Design

Trial Locations

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